NCT01822886已完成2 期
Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Complete Remission (CR) Rate
研究概览
简要总结
Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL (peripheral T-cell lymphoma) in a selected population of patients.
详细描述
Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological diagnosis of PTCL according to the WHO (World Health Organization) classification
- •Age ≥ 18 years
- •Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy
- •Stage I-IV according to the Ann Arbor staging System
- •ECOG (Eastern Cooperative Oncology Group) Performance status ≤2
- •Normal renal and hepatic functions
- •Laboratory test results as follows:
- •Serum creatinine ≥ 2.0 mg/dL
- •Total bilirubin ≥ 1.5 mg/dL
- •AST (SGOT) and ALT (SGPT) £2 x ULN or £5 x ULN if hepatic metastases are present
- •Negative HIV HCV and HBV status
- •Adequate bone marrow reserve: Platelet count>100X109 cells/L or platelet count <75X109 cells/L if bone marrow disease involvement, absolute neutrophile count (ANC)> 1,5 X109, hemoglobin>8 g/dl.
- •Able to adhere to the study visit schedule and other protocol requirements
- •Cardiac ejection fraction (MUGA scan or echocardiography) > 45%
- •Life expectancy > 6 months
- •Females of childbearing potential (FCBP) must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
- •Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug.
- •Measurable disease of at least 2 cm as detected by CT scan, assessed by site radiologist
- •Patients or they legally authorized representative must provide written informed consent
排除标准
- •Any serious active disease or co-morbid medical condition (according to investigator's decision)
- •Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation
- •Corrected QT interval > 480 msec (using the Fridericia formula)
- •Low K+ (<3.8 mmol/L) and low Mg+ (<0.85 mmol/L) levels, except if corrected before beginning the chemotherapy
- •Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study
- •Previous exposure to romidepsin or gemcitabine
- •CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
- •History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- •Active opportunistic infection
研究组 & 干预措施
Romidepsin, Gemcitabine
Experimental
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD (progression disease)
干预措施: Romidepsin + Gemcitabine (Drug)
结局指标
主要结局
Complete Remission (CR) Rate
时间窗: 18 months
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
次要结局
- Percentage of Participants With Progression-Free Survival(24 months)
- Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death(24 months)
- Overall Response Rate (ORR)(24 months)
- Safety - Frequency of Toxicities Grade 3 and 4(24 months)
研究者
研究点 (4)
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